Protocol summary

Summary
The main objective of this project is the study of magnesium sulfate capability for inducing controlled hypotension for reducing blood loss during posterior fusion of spine and comparing that with the effects of remifentanil. The study designed as a prospective randomized double blind clinical trial in two groups (magnesium & remifentanil). The inclusion criteria includes: patients with 20- 60 years old, and ASA I & II physical status in candidates for posterior fusion of lumbar spine. Patients with the history of systemic cardiovascular, hepatic and renal diseases as well as those with allergic reaction to magnesium and remifentanil were excluded. Then 40 patients were allocated randomly into two equal groups. After induction of anesthesia and placing the patients in prone position and making sure that they are hemodynamically stable, in group I, a loading dose of magnesium (50 mg/kg) was administered in 10 min and then a 15mg/kg were infused continually during operation. And in the second group, infusion of remifentanil 0.1- 0.2µg/kg/min instead of magnesium sulfate was used. The remaining anesthetic drugs and techniques are the same for both groups. The aim of this intervention is the reduction of mean arterial pressure to 60-75 mmHg. If the success could not be achieved in 10 min, infusion of TNG will be started and documented for comparison between groups. In addition, amount of blood loss, total fluid therapy, and need for transfusion, urine output, satisfaction of surgeons from the surgical field, and hemodynamic variables will be recorded. Complications such as arrhythmias, bradycardia, hypotension and therapeutic intervention for them also shall be recorded and compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111138091N1
Registration date: 2012-02-06, 1390/11/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-02-06, 1390/11/17
Registrant information
Name
Kourosh Farazmehr
Name of organization / entity
Tehran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 4408 6963
Email address
koroushfaraz@irimc.org
Recruitment status
Recruitment complete
Funding source
Research Vice chancellor of TUMS
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison between the quality of controlled hypotension induced by Magnesium sulfate & Remifentanil in Lumbar PSF surgery
Public title
Controlled hypotension due to magnesium sulfate and remifentanil
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include: Individuals between 20-60 years old, candidate for PSF surgery, ASA I & II physical status, signing informed consent of study Exclusion Criteria includs: Allergic reaction to drugs, Liver, renal, cardiovascular failure, Ventricular and atrial arythmia and conduction heart disorders, Opioid consumption and drug abuse, Chronic therapy with opioids, NSAIDs and calcium channel blockers
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Medicine, Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Poursina St.
City
Tehran
Postal code
14736
Approval date
2010-03-02, 1388/12/11
Ethics committee reference number
42114

Health conditions studied

1

Description of health condition studied
Instability of Lumbar Spine
ICD-10 code
S33.3
ICD-10 code description
Dislocation of other & unspecified parts of lumbar spine & pelvis

Primary outcomes

1

Description
Mean arterial pressure
Timepoint
Continuous monitoring
Method of measurement
Invasive blood pressure monitorig with transducer and monitoring device

2

Description
Blood loss
Timepoint
During operation
Method of measurement
Calculating the amount of blood in the suction, surgical field and towels in cc

Secondary outcomes

1

Description
Prevalence of transfusion in two groups
Timepoint
End of surgery
Method of measurement
Recording patients who need for transfusion and number of blood packs

2

Description
Arrhythmia
Timepoint
During operation
Method of measurement
Continuous ECG monitoring

3

Description
Bradycardia
Timepoint
During operation
Method of measurement
Continuous ECG monitoring

4

Description
Hypotension
Timepoint
During operation
Method of measurement
Continuous IBP monitoring

5

Description
Prevalence of need for TNG administration
Timepoint
Throughout the operation
Method of measurement
Recording patients who need TNG for controlling blood pressure

Intervention groups

1

Description
In group 1, Magnesium sulfate was administered with loading dose of 50mg/kg IV in 100cc Normal saline over 10 min, then with infusion pump the maintenance dose of magnesium sulfate (15mg/kg/h) was administered until 30 min before the end of operation.
Category
Treatment - Drugs

2

Description
In the second group remifentanil was administered until the end of operation with maintenance dose of 0.1- 0.2 microgram/kg /min IV with infusion pump.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthopedic & neurosurgical clinic in Hazrate Rasoul Hospital
Full name of responsible person
Kourosh Farazmehr
Street address
Rasoul-e-Akram hospital, Niayesh St, Satar Khan Av.
City
Tehran

2

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Mohammad Reza Ghodraty
Street address
Behafarin St, Karim Khan Av.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research vice-chancellor of Medicine faculty, Tehran university of medical sciences
Full name of responsible person
Dr. Sahin Akhondzade Basti
Street address
Medical school, Porsina St, Keshavarz Blvd.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice-chancellor of Medicine faculty, Tehran university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Kourosh Farazmehr
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Anesthesiology department, Hazrate Rasol Akram Hospital, Niayesh St.
City
Tehran
Postal code
1473635381
Phone
+98 21 4408 6963
Fax
+98 21 6600 1123
Email
koroushfaraz@irimc.org
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Mohamad Reza Ghodraty
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesia Department, Firozgar hospital. Behafarin St, Karim Khan Av.
City
Tehran
Postal code
1593748711
Phone
+98 21 8894 6762
Fax
+98 21 8894 2622
Email
m-ghodrati@sina.tums.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Kourosh Farazmehr
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
No.11, Golzar11, Hejrat St, Bahonar St.
City
Tehran
Postal code
1473635481
Phone
+98 21 4408 6963
Fax
+98 21 6600 1123
Email
koroushfaraz@irimc.org
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...